Smile Stream STEP-1 PumEtch

GUDID 07290115051889

B.J.M. LABORATORIES LTD

Dental prosthesis priming agent

• Primary Device ID: 07290115051889
• NIH Device Record Key: db25f0c3-0f77-45ce-9b14-00bf27c85648
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smile Stream STEP-1 PumEtch
• Version Model Number: 9000-1000
• Company DUNS: 514764117
• Company Name: B.J.M. LABORATORIES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290115051889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213093

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13

Devices Manufactured by B.J.M. LABORATORIES LTD

• 07290115050400 - High-Q-Bond SE: 2026-03-30
• 07290115050523 - BJM Root Canal Sealer: 2026-03-30
• 07290115050035 - High-Q-Bond Bracket Adhesive: 2026-03-23
• 07290115050196 - Prima Quick Prime: 2026-03-23
• 07290115053340 - Quick Seal: 2026-03-23
• 07290115051889 - Smile Stream STEP-1 PumEtch: 2026-03-23
• 07290115051889 - Smile Stream STEP-1 PumEtch: 2026-03-23
• 07290115051896 - Ideal 1 Orthodontic Bracket Adhesive: 2026-03-23
• 07290115051902 - High-Q-Bond Band: 2026-03-23